Cardinal Health Mexico 244 S de RL de CV

FDA Device Registration & Listing · Ciudad Juarez Chihuahua, MX · Registration 9616099

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
9616099
FEI Number
3003528016
Entity Name
Cardinal Health Mexico 244 S de RL de CV
City/State/Country
Ciudad Juarez Chihuahua, MX
Establishment Address
Santiago Troncoso #808, PARQUE INDUSTRIAL SALVARCAR, Ciudad Juarez Chihuahua CP 32575, MX
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Cordis US Corp. (Owner Number: 1016427)
Owner / Operator Contact Address
5452 Betsy Ross Drive, --, Santa Clara, CA 95054, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
P020036

All Registered Proprietary Names

Vessel Dilator Vista Brite Tip Catheters RAIN Sheath™ Tibial Pedal Introducer AVANTI+ Catheter Sheath Introducer Trapease Permanent Vena Cava Filter Frontrunner OPTEASE Vena Cava Filter and OPTEASE Retrieval Catheter Exoseal® Vascular Closure Device Brite Tip Catheter Enroute Transcarotid Stent System Vista Brite Tip Guiding Catheters Cordis EXOSEAL Vascular Closure Device S.M.A.R.T. CONTROL Nitinol Stent Transhepatic Biliary System (modification) CORPAC - Cardiovascular Procedure Kit PROPAC Diagnostic Procedural System PRIMOPAC - Cardiovascular Procedure Kit Angiographic Catheter Extension PRECISE NITINOL STENT SYSTEM Smart Stent 5F SuperTorque Diagnostic Catheter Avanti Trans-radial sheath introducer kit CORDIS WEBSTER PREFACE BRAIDED GUIDING SHEATH & PERRY EXCHANGE DILATOR Modification to Smart Control S.M.A.R.T. RADIANZ Vascular Stent System S.M.A.R.T. CONTROL and S.M.A.R.T. Vascular Stent System Trapease Permanent Vena Cava Filter Brite Tip Sheath Introducer ADROIT Guiding Catheter 4F Tempo Aqua Diagnostic Catheter Envoy and Vista Brite Tip ( modification) Vista Brite Tip Catheters S.M.A.R.T. RADIANZ Vascular Stent System S.M.A.R.T. and S.M.A.R.T. CONTROL Nitinol Stent System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2007-12-04
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2007-12-04
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2023-04-26
DRE Dilator, Vessel, For Percutaneous Catheterization Cardiovascular Class 2 870.1310 2006-03-16
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2011-12-05
PDU Catheter For Crossing Total Occlusions Cardiovascular Class 2 870.1250 2011-12-06
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2011-12-06
DTK Filter, Intravascular, Cardiovascular Cardiovascular Class 2 870.3375 2014-06-09
MGB Device, Hemostasis, Vascular Unknown Class 3 N/A 2016-07-27
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2007-12-04
NIM Stent, Carotid Unknown Class 3 N/A 2016-07-27
NIM Stent, Carotid Unknown Class 3 N/A 2019-05-02
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2007-12-04
MGB Device, Hemostasis, Vascular Unknown Class 3 N/A 2011-05-20
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2006-03-02
OEZ Cardiovascular Procedure Kit Cardiovascular Class 2 870.1200 2024-03-14
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2025-01-09
NIM Stent, Carotid Unknown Class 3 N/A 2006-10-17
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2011-12-06
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2007-12-04
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2007-12-04
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2024-06-06
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2011-12-06
NIP Stent, Superficial Femoral Artery Unknown Class 3 N/A 2012-12-06
DTK Filter, Intravascular, Cardiovascular Cardiovascular Class 2 870.3375 2011-12-06
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2007-12-04
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2013-06-06
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2007-12-04
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2007-12-04
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2007-12-04
NIO Stent, Iliac Unknown Class 3 N/A 2006-03-02

Official Correspondent

Linda Ruedy

US Agent Details

Linda Ruedy Business: Cordis US Corp. Email: DL-Cordis-Regulatory@Cordis.com Phone: (408) 8576754

Related Public Records

Same Entity

Cordis US Corp.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3004939290 Cordis US Corp. Santa Clara, CA, US
1016427 Cordis US Corp. Miami Lakes, FL, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K101883 St Jude Medical 6F ENGAGE/ENGAGE TR INTRODUCER 2010-09-07
K034025 Nmt Medical, Inc. NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC 2004-03-26
K122854 Arrow International (Subsidiary of Teleflex Inc.) ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER 2013-01-04
K233691 Acutus Medical, Inc. FlexCath Cross Transseptal Solution 2023-12-17
K915078 North American Instrument Corp. MORSE HEMOSTATIC CATHETER INTRODUCER SET 1992-06-10

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0783-2020 Abbott Medical 2
Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303
Z-0789-2020 Abbott Medical 2
Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are indicated for the introduction of angiographic catheters, closed-end catheters, balloon catheters, and electrodes into a vessel where minimizing blood loss is essential.
Z-0001-2010 Penumbra Inc. 2
Penumbra Neuron Delivery Catheter 070, percutaneous catheter, catalog numbers PND6F0701058, PND6F070956, PND6F0701058M, and PND6F070956M; manufactured by Penumbra, Inc., Alameda, CA. Indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
Z-0003-2014 Cordis Corporation 2
Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.
Z-0009-2024 Boston Scientific Corporation 2
Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9616099. Last updated year: 2026. Please use registration number 9616099 when referencing this establishment in official correspondence.
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